tipifarnib in treating patients with recurrent bladder cancer

Conditions: Bladder Cancer

Summary: rationale: tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. purpose: phase ii trial to study the effectiveness of tipifarnib in treating patients who have recurrent bladder cancer.

objectives: * determine the 1-year recurrence-free survival rate of patients with stage 0 or i recurrent transitional cell carcinoma of the bladder treated with tipifarnib. outline: this is a multicenter study. patients receive oral tipifarnib twice daily on days 1-21. treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 37 patients will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed transitional cell carcinoma (tcc) of the bladder with or without associated carcinoma in situ * stage 0 or i (ta or t1) * grade 1, 2, or 3 tcc * cystoscopically and histologically confirmed recurrent disease after at least 1 course of standard first-line intravesical therapy (e.g., bcg or mitomycin) within the past 12 months * complete transurethral resection of bladder tumor performed within past 4 weeks * rendered clinically and cystoscopically tumor free * negative cytology * no upper tract tcc by intravenous pyelogram, retrograde pyelogram, or ct scan of kidneys (with contrast) patient characteristics: age * 18 and over performance status * ecog 0-2 or * karnofsky 60-100% life expectancy * more than 1 year hematopoietic * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin normal * ast/alt no greater than 2.5 times upper limit of normal (uln) renal * creatinine no greater than 1.25 times uln or * creatinine clearance at least 60 ml/min cardiovascular * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * no uncontrolled hypertension other * able to swallow and retain oral medication * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior allergic reactions to compounds of similar chemical or biological composition to study drug (e.g., other imidazoles such as ketoconazole and other imidazole-based antifungal agents, losartan, metronidazole, or cimetidine) * no other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer * no other uncontrolled concurrent illness that would preclude study participation * no ongoing or active infection * no active peptic ulcer disease * no psychiatric illness or social situation that would preclude study participation prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics * no prior systemic chemotherapy for bladder cancer endocrine therapy * not specified radiotherapy * no prior radiotherapy for bladder cancer surgery * see disease characteristics other * no single-dose post-transurethral resection (tur) adjuvant intravesical therapy (after tur that is performed immediately preceding study entry) * at least 4 weeks since prior investigational agents * no concurrent commercial or other investigational agents or therapies for malignancy * no other concurrent therapy for bladder cancer * no concurrent combination anti-retroviral therapy for hiv-positive patients

Keywords: recurrent bladder cancer stage 0 bladder cancer stage i bladder cancer transitional cell carcinoma of the bladder